Determining Parental Attitudes Toward Day of Surgery Consent for Research

NCT ID: NCT04613505

Last Updated: 2025-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

214 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-22

Study Completion Date

2022-12-31

Brief Summary

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There are no studies examining parents' attitudes towards day of surgery consent for research. The purpose of the study is to determine the attitudes parents of potential research participants have toward being approached for day of surgery consent. The primary objective is to determine parental attitudes regarding day of surgery consent for anesthesia research. The secondary objective is to determine the boundaries for day of surgery consent (e.g., study types, interventions, risk factors).

Detailed Description

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This is a multi-phase prospective cohort study. In the first phase the investigators will interview parents and consult the Family Research Advisory Committee (FRAC) to determine their attitudes toward day of surgery research consent. The investigators will use the participants' responses and instruments already found in the literature to develop the questionnaire. In the second phase, the investigators will interview parents and consult FRAC about the questionnaire to determine which items to add, remove, or modify. In the third phase, the investigators will distribute the adapted questionnaire to clarify parents' attitudes surrounding day of surgery consent. The investigators will use the results of the third phase to develop a table of guidelines for day of surgery consent. In the final phase, the investigators will interview parents, healthcare professionals, and consult FRAC for feedback and modification of the table of guidelines.

Conditions

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Surgery Consent

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Phase 1: Instrument Development

Parents will be asked to participate in a semi-structured interview with one of the researchers that will explore their attitudes toward day of surgery consent. Particular attention will be given to a) study designs, b) previous research experience, and c) previous medical experiences.

Semi-structured interview

Intervention Type BEHAVIORAL

Participants will be asked a set of questions as applicable to each phase. Researchers will be able to ask additional questions as they arise within each interview.

Phase 2: Questionnaire Adaptation

Parents will be given approximately 5 minutes to review a questionnaire we developed using participant responses in Phase 1. After reviewing the questionnaire, participants will be asked to participate in a semi-structured interview with one of the investigators.

Semi-structured interview

Intervention Type BEHAVIORAL

Participants will be asked a set of questions as applicable to each phase. Researchers will be able to ask additional questions as they arise within each interview.

Phase 3: Questionnaire Application & Development of Day of surgery consent Table of Guidelines

Participants will be asked to complete the questionnaire developed in Phase 2.

Same day consent questionnaire

Intervention Type BEHAVIORAL

A questionnaire (yet to be developed) will be administered to participants.

Phase 4: Table of Guidelines Refinement

Participants will be given approximately 5 minutes to review the table of guidelines developed in Phase 3. After reviewing the guidelines, participants will be asked to participate in a semi-structured interview with one of the investigators.

Semi-structured interview

Intervention Type BEHAVIORAL

Participants will be asked a set of questions as applicable to each phase. Researchers will be able to ask additional questions as they arise within each interview.

Interventions

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Semi-structured interview

Participants will be asked a set of questions as applicable to each phase. Researchers will be able to ask additional questions as they arise within each interview.

Intervention Type BEHAVIORAL

Same day consent questionnaire

A questionnaire (yet to be developed) will be administered to participants.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* The parents of children undergoing elective surgical procedures at Sickkids will be invited to participate in the study.
* If multiple parents are present, they are permitted to participate jointly; however, their participation will count as a single response.

Exclusion Criteria

-Parents of children who are undergoing urgent or add-on procedures will be excluded.
Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Katherine Taylor

Staff Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katherine Taylor

Role: PRINCIPAL_INVESTIGATOR

Staff Anesthesiologist

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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1000066221

Identifier Type: -

Identifier Source: org_study_id

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